경천애인Gyeongcheon-Aein and 진천사대천명Jincheonsa-Daecheonmyung. These are words that Dr. Ra Jung-chan, CEO of Nature Cell, always keeps in mind. It means “I respect God and love my neighbor like my own body,” and “I wait for heaven’s help after doing my best for the work that God has called me to do.”
At an art museum in Gwacheon, near Seoul, on April 28 afternoon, Dr. Ra Jung-chan explained the vision of his companies, Bio-star and Nature Cell at a corporate briefing with about 100 shareholders, industry officials and reporters that had gathered. Just before that day, the corporate briefing session drew public attention as it handled “JointStem”, which was developed to treat degenerative arthritis using stem cells derived from autografts, received approval from the U.S. FDA for phase 3 clinical trials and also applied to the FDA for clinical tests to treat lung diseases caused by COVID-19 using homogeneous fat-derived stem cells.
At the briefing session, Dr. Ra continued his 50-minute briefing and 10-minute question-and-answer session with confidence. His explanation was easy and clear enough for anyone to understand.
Just two months ago, South Korea’s judiciary discharged all of the cases in which prosecutors indicted Ra and his company’s key executives on charges of stock price manipulation and other charges. According to Ra’s lawyer, it was a ruling destined from the beginning as the prosecutors indicted the criminal charges by force.
It may be unfair, but he didn’t say a word about it at the briefing session. He just said, “Our research began with a calling to save all mankind from disease, and I am immersed in it.” “This is God’s mission and gift to me,” he continued.
He explained the items his company is researching and developing, citing specific and practical examples. He introduced in detail the current development and clinical trials of Jointstem, AlKOSTem, Astrostem-VV, and the rehabilitation medical sector.
More specifically, Jointstem, which was developed to treat degenerative arthritis with the world’s first autograft-derived mesenteric stem cells, is currently undergoing a three-phase clinical trial in Korea, and the FDA has approved a 2b/3a clinical trial in the U.S., which will soon begin a full-fledged clinical trial.
According to Ra, clinical trials for phase 3 in Korea are conducted on 260 patients at 13 university hospitals across the country, including the Seoul National University Hospital. Currently, the recruitment of patients participating in clinical trials is nearing its final stage, and the administration of clinical trials drugs will be completed in June, and the plan is to complete follow-up observations within this year. It then aims to apply for the KFDA’s item license within the end of March 2021.
In the U.S. above 2b/3a, Jointstem clinical trials were launched on April 19 in accordance with FDA regulations. In particular, U.S. clinical researchers have confirmed Professor Javad Parvizi of Thomas Jefferson University and Dr. Timothy Davis as U.S. 2b/3a researchers. “The U.S. 2b/3a Award aims to apply for FDA conditional item licensing in 2023,” Ra said.
AlKaostem’s U.S. phase 2 clinical trial, developed by the company for treatment of Alzheimer’s, is also in sight. With the completion of the first two-phase result report in December 2019 and the final completion of the second phase protocol in April, the company will apply to the FDA this month for the second phase IND. The day when treatment of Alzheimer’s patients using stem cells will become a reality is even closer.
This year, the whole world is facing a crisis due to the worst infectious disease in history called Covid 19. That’s why Dr. Ra and Biostem Cell Institute of Technology have started to develop AstrostemV. Astrostem V is a pneumonia drug created to fight COVID19 and has now sought approval from South Korea and the United States for a one-half-a clinical trial. In the U.S., it has completed a 1/2a phase IND application to the FDA on the 17th of last month, and if no decision is made to put it on hold, it will virtually enter the clinical trial stage after 18th.
It is speeding up clinical trials of a half-a-phase to explore the safety and effectiveness of similar lipid-derived mesenchymal stem cells, or astrostemV treatments, for people with lung diseases caused by Corona infection.
Dr. Ra Jung-chan, who is considered one of the world’s leading researchers in the stem cell field, often, said, “Stem cells are the gift of life. I seek wisdom from God and won’t stop my research until the end to conquer cancer and viruses.”
There is another reason why he seeks God’s wisdom and providence. The Advanced Regenerative Bio Act, which passed the National Assembly last summer, will take effect on Aug. 28, which means stem cell treatment, which has been illegal in Korea and has been done overseas, including Japan and China, has become legal in Korea. Moreover, what is ironic is that six years later a lawmaker, who illegally drove stem cell treatments from Ra’s company into a major crisis in the National Assembly in 2013, stood in a position to promulgate related laws.
Dr. Ra said, “I will walk honestly,” and added, “I firmly believe that the management of the mind is on the human side, but the results depend on God alone.” (Courtesy: TheAsiaN, Seoul, South Korea)